TIDMOXP
RNS Number : 5108H
Oxford Pharmascience Group PLC
08 June 2017
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Further Update Regarding OXPzero(TM) Ibuprofen Programmes
Oxford Pharmascience Group plc (AIM: OXP), the specialty
pharmaceutical company that redevelops medicines to make them
better, safer and easier to take, is providing a further update
regarding its clinical and commercial plans, centred on its
OXPzero(TM) NSAID (non-steroidal anti-inflammatory drug)
portfolio.
Summary
OTC (Over the counter products):
-- Proceeding to develop selected OTC products with the
intention to register for approval those which have a compelling
business case, lower clinical risk and simple regulatory
pathway
- Lead OTC programme already initiated
- Further market research being initiated to validate and
prioritise other compelling OTC opportunities
Rx (Prescription based products):
-- Commercialisation efforts underway for Rx candidates in
selected regions with favourable regulatory frameworks
-- Further clarification to be sought from regulatory agencies
for 'GI (gastrointestinal) symptoms' endpoint and regulatory
pathway
Funding
-- Strong capital base to support strategic objectives
Further detail in relation to the Company's plans is provided
below under the same key headings.
OTC
As announced on 9 May 2017, the Company considers that the
regulatory path to approval for products without a GI safety claim
in the USA and UK/EU provides an attractive, low-risk route to
market for a number of its pipeline OXPzero(TM) products. Having
established that it can develop OXPzero(TM) Ibuprofen products that
are bioequivalent to reference products, the Company sees
opportunity to progress selected ibuprofen-based, taste masked
products to the OTC market.
The Company is initiating market research in Europe and the USA
to validate the most attractive opportunities and has already
identified and started work on a lead programme. The Company's
objective is to get the chosen product or products fully developed
and approved for sale in at least one major geography and then to
seek to commercialise via out-license, product launch or both.
Rx
For Rx markets, the Company's technology provides several,
clinical-stage, high-value candidates available for licensing which
solve key unmet needs across multiple pain markets. Our OXPzero(TM)
products are clinically proven to have fewer GI side effects
compared to standard form NSAIDs, enhancing safety and simplifying
therapy. OXPzero(TM) Ibuprofen is demonstrably faster (and at the
same time with fewer /reduced GI side effects') than standard
ibuprofen tablets, providing faster onset and potentially faster
pain relief.
For territories where the regulatory pathway to a 'GI-safer'
label claim involves endoscopic trial endpoints, the Company will
continue to look to form commercial partnerships to maximize value.
Following the regulatory guidance received from the US FDA in
April, the Company has conducted market research both in the UK and
in the USA to assess prescriber reaction to various Rx product
concepts and label claims to help define its Rx strategy. This
research has concluded:
-- As suggested by the FDA, claims of 'reduced GI symptoms"
rather than 'GI safe' are considered to be sufficient to drive a
prescription switch from other NSAIDs to OXPzero(TM) Ibuprofen,
provided that reimbursement is at an acceptable level. The Company
will now re-engage with the regulatory agencies to clarify the
regulatory pathway for a 'reduced GI symptoms' label claim.
-- The speed of onset advantage associated with OXPzero(TM)
Ibuprofen could also drive a switch of prescriptions, especially
from diclofenac. Diclofenac is a fast-acting NSAID prescribed for
acute pain but its usage is associated with higher cardiovascular
risk than other NSAIDs.
-- Ketorolac is acknowledged as an excellent pain reliever and
the potential to develop a GI-safer version would be well received
in the post-operative and acute pain markets where opioids are
traditionally used, but should be avoided or used for limited
periods only, due to the risk of opioid overdose and the high
levels of addiction associated with use.
The Company now will begin investigations to understand the
regulatory pathway and the associated reimbursement scenarios for
these various opportunities across several geographies, so as to
inform the business case to prospective partners. The Company will
seek partnerships to complete development and commercialisation of
these assets.
Sole focus on OXPzero(TM) NSAIDs
In order to ensure focus on its lead NSAID programmes, the
Company has decided not to progress its cardiovascular programmes
further at this time.
Strong cash balance
The Company maintains a strong capital base which supports the
attainment of the Group's strategic objectives, with cash balances
of GBP21.5 million as at 30 April 2017.
Further announcements including financial implications will be
announced in due course.
Contacts:
Oxford Pharmascience Group plc
Marcelo Bravo, Chief Executive
Officer +44 20 7554 5875
N+1 Singer (Nominated Adviser
& Broker)
Aubrey Powell +44 20 7496 3000
Lauren Kettle
About Oxford Pharmascience Group Plc
Oxford Pharmascience Group Plc uses a range of proprietary
technology platforms to re-develop existing medicines to make them
better, safer or easier to take. The Company does not manufacture
or sell its own pharmaceutical products direct to consumers, but
instead seeks to license its technologies and dossiers to a network
of partners, mainly leading pharmaceutical companies with Rx
(prescription) and OTC (over the counter) branded portfolios.
Oxford Pharmascience Group Plc focuses on existing medicines
that are proven to be safe and effective but nevertheless still
have associated issues and side effects often affecting compliance.
By working with such medicines, the Company is able to develop new
innovative products for a fraction of the cost, in much quicker
timescales and without the high risk of failure associated with
developing new drugs.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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